Fully Burdened Manufacturing Costs means costs to supply applicable therapeutic ingredients, finished products, related inputs and services (a) supplied by an unaffiliated Third Party or (b) manufactured directly by Bluebird; it being understood and agreed that (i) in the case of costs referred to in clause (a) of this sentence where an unaffiliated Third Party is the manufacturer, Fully Burdened Manufacturing Costs will equal [***], and (ii) in the case of costs referred to in clause (b) of this sentence where Bluebird is the manufacturer, Fully Burdened Manufacturing Costs will equal [***]
Fully Burdened Manufacturing Costs means ***.
Examples of Fully Burdened Manufacturing Costs in a sentence
During the Term, PerImmune shall keep for at least three (3) years records of its Fully Burdened Manufacturing Costs, and the calculations thereof in sufficient detail to permit Progenics designee, reasonably acceptable to PerImmune, to confirm the accuracy thereof.
If any review reveals a deficiency in the calculation of Fully Burdened Manufacturing Costs resulting from any overpayment by GENENTECH, IMMUNOGEN shall promptly refund GENENTECH the amount of any such overpayment (plus interest thereon at the rate provided in Section 4.6 above), and if such overpayment is by [***] percent ([***]%) or more, IMMUNOGEN shall pay all costs and expenses of the review.
The price of Product ordered by Green Cross under this Section 6.2 will be equal to *** of MacroGenics’ Fully Burdened Manufacturing Costs for such material.
During the Term, CBC shall keep for at least three (3) years records of its Fully Burdened Manufacturing Costs, and the calculations thereof in sufficient detail to permit Progenics to confirm the accuracy thereof.
First, 1] equity costs can be seen as the related cost to equity issue and may be included as monitoring expenses for the equity holders (Jensen, 1986).
More Definitions of Fully Burdened Manufacturing Costs
Fully Burdened Manufacturing Costs shall have the meaning ---------------------------------- set forth in the Original Agreements.
Fully Burdened Manufacturing Costs means, with respect to a Product, Sutro’s costs of manufacturing such Product, which manufacturing costs shall mean: (a) [***], and (b) [***], in each case to the extent directly allocated to and incurred in the manufacture by Sutro of such Product supplied to SutroVax, its Affiliates and Sublicensees. Fully Burdened Manufacturing Costs shall not include any [***] and shall be calculated in accordance with the foregoing, GAAP and Sutro’s policies and procedures for its other products, in each case consistently applied (and such plant operations and support services costs shall be allocated consistent with GAAP and other products of Sutro in that facility).
Fully Burdened Manufacturing Costs means the actual fully burdened costs and expenses of manufacturing a particular Component, including without limitation the costs of all raw materials and labor (including all allocable benefits) used or consumed in such manufacture, Third Party contract manufacturing costs, packaging costs and expenses, all quality assurance and quality control related expenses, all overhead amounts allocable to such manufacturing (including without limitation appropriately amortized capital equipment costs), all royalty amounts payable by Supplier to any Third Party based upon the manufacture of such Component, and all amounts related to failed production units or yield losses, all the foregoing as calculated in accordance with (i) U.S. generally accepted accounting principles consistently applied for manufacture of Components by Dendreon and (ii) Japan's generally accepted accounting principles consistently applied for manufacture of Components by Kirin.
Fully Burdened Manufacturing Costs means, as applicable to a Collaboration Compound or Collaboration Product, a Party’s cost of manufacturing such Collaboration Compound or Collaboration Product for clinical purposes, which is equal to the sum of (a) for Collaboration Compounds or Collaboration Products (or components thereof) made by a Party, the costs of all *, in each case for the manufacture of such Collaboration Compound or Collaboration Product, (b) for Collaboration Compounds or Collaboration Products (or components thereof) made by a Third Party, *, and (c) *; to the extent such costs in (a), (b) and (c) above are incurred by a Party or its Affiliates and to the extent they are reasonably allocable to the manufacture of such Collaboration Compound or Collaboration Product. Fully Burdened Manufacturing Cost shall be calculated in a manner consistent with applicable GAAP.
Fully Burdened Manufacturing Costs means, with respect to any Licensed Product supplied by or on behalf of Entasis to Zai hereunder:
(a) if such Licensed Product (or any precursor or intermediate thereof) is manufactured by a Third Party manufacturer, (i) the amount paid by Entasis to such Third Party to acquire such Licensed Product, plus (ii) any internal costs incurred by Entasis in association with such manufacturing, including for reasonable overhead, process development, project management (at the FTE Rate), manufacturing oversight (including at the FTE Rate for any Entasis person-in-plant), and quality control and assurance; or
(b) if such Licensed Product (or any precursor or intermediate thereof) is manufactured by Entasis or its Affiliates, the actual, fully burdened cost of such manufacturing, including the cost of raw materials, direct labor and benefits, a proportionate share of indirect manufacturing costs, including intellectual property acquisition and licensing costs (including royalties, upfront fees) paid by Entasis with respect to the manufacture of such Licensed Product, and all other reasonable and customary manufacturing-related costs for such Licensed Product, including actual product inventory write-offs, factory, plant or equipment start-up or start-up amortization costs, scale-up expenses, and freight in/out and sales and excise taxes imposed thereon, customs and duty and charges levied by government authorities, and all costs of packaging. Such fully burdened costs shall be calculated in accordance with GAAP.
Fully Burdened Manufacturing Costs means costs to perform Manufacturing Services and to supply a Moderna mRNA API and related inputs and services [***]; it being understood and agreed that:
(i) in the case of costs referred to [***] of this sentence [***]; provided, that [***]; and
(ii) in the case of costs referred to [***] of this sentence [***], which Manufacturing costs: (x) will include [***], (y) will be calculated in accordance with [***] and (z) notwithstanding anything to the contrary, will exclude [***].
Fully Burdened Manufacturing Costs means the cost of Manufacturing the Licensed Product. Fully Burdened Manufacturing Costs shall be a “standard cost” per unit (calculated annually), comprised of the following elements calculated in accordance with GAAP: [***]. To the extent that Licensed Products are sourced from one or more CMOs by Deciphera, Fully Burdened Manufacturing Costs shall be the actual invoiced price paid by Deciphera to such CMO(s) for the manufacture and supply of a Licensed Product.